FDA Radiology AI Devices

The SIS System (Version 5.1.0) is a medical imaging software that helps surgeons, neurologists, and radiologists visualize specific brain structures such as the subthalamic nuclei and globus pallidus from MRI and CT scans. It uses advanced deep learning models to create 3D anatomical models to aid in stereotactic surgical planning and lead placement, improving visualization and accuracy during procedures.

VBrain is an AI-powered software device that helps trained medical professionals by automatically generating initial contours of known brain tumors on MRI scans. It supports radiation therapy planning by providing preliminary tumor outlines for professionals to review and adjust, streamlining the clinical workflow for brain tumor treatment planning.

Imbio RV/LV Software is an AI-powered medical imaging tool that automatically measures the diameters of the right and left ventricles of the heart from CT pulmonary angiography scans. It provides annotated images and reports to assist physicians in evaluating heart function, supporting clinical decision-making as part of cardiac assessment workflows.

TruPlan is a medical software that helps doctors visualize and measure heart and vessel structures from CT scans to assist in planning the left atrial appendage closure procedure. It provides tools such as segmentation, 3D rendering, and simulated imaging views to support detailed anatomical assessment and device sizing for safe and effective treatment.

Synapse 3D Base Tools v6.1 by Fujifilm is an advanced medical imaging software designed to assist trained medical professionals in viewing, analyzing, and interpreting medical images from a variety of modalities such as CT, MRI, PET, and ultrasound. It provides multi-planar reconstructions, 3D volume rendering, image fusion, segmentation using deep learning algorithms, and other sophisticated tools to support diagnosis and treatment planning, enhancing the workflow and accuracy for radiologists and clinicians.

ART-Plan is a medical software tool that helps clinicians plan radiation therapy for cancer patients. It supports image registration and fusion of CT, PET, and MRI scans to better visualize tumor and healthy tissues. It offers automatic, semi-automatic, and manual contouring of organs at risk and lymph nodes, saving time and improving precision in treatment planning. The software is meant for use by trained professionals in clinical settings.

Hepatica v1 is a software tool used by clinicians to analyze MRI scans of the liver. It processes MRI data to create detailed 3D models of the liver by segments and provides quantitative measurements of liver tissue health such as iron-corrected T1 and fat fraction. This information supports the evaluation of liver volume and health, aiding clinical and surgical decision making for patients.

BrainInsight is a software tool designed to analyze low-field MRI brain scans automatically. It uses machine learning to segment brain structures, measure volumes, and provide annotated images and reports to assist clinicians in evaluating brain anatomy quickly and efficiently.

CorInsights MRI is an automated software that processes brain MRI scans to identify and measure brain structures. It helps clinicians by providing detailed volumetric reports comparing patient brain volumes to normal reference data, aiding in research and clinical assessment of neurologic conditions in adults 45 to 95 years old.

PROView is a software tool designed to help clinicians review and analyze prostate MRI scans by automatically segmenting the prostate gland and assessing lesions using AI-based deep learning techniques. It supports the evaluation of prostate lesions according to PI-RADS guidelines, providing measurements, scoring, and reporting functionalities to assist in diagnosis and treatment planning for prostate conditions.